Recruitment

Recruitment Status
Completed
Estimated Enrollment
120

Inclusion Criterias

Free of a lifetime Axis I or Axis II diagnosis
Free of a lifetime Axis I or Axis II diagnosis

Exclusion Criterias

Current or past Axis I psychiatric disorder [including alcohol/substance abuse of dependence disorder]
Current or past Axis I psychiatric disorder [including alcohol/substance abuse of dependence disorder]

Summary

Conditions
Post-Traumatic Stress Disorder
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Basic Science

Participation Requirements

Age
Between 21 years and 45 years
Gender
Both males and females

Description

The total time that for each participant involved in this study is 4 visits, as outlined below: Visit 1: Questionnaires, Screening, and Orientation: During this visit the potential participant will learn about the study procedures, sign the informed consent documents, and fill out a packet of forms ...

The total time that for each participant involved in this study is 4 visits, as outlined below: Visit 1: Questionnaires, Screening, and Orientation: During this visit the potential participant will learn about the study procedures, sign the informed consent documents, and fill out a packet of forms that ask about his or her race and ethnic background, use of drugs and alcohol and physical and mental health. Visit 2: Behavioral Tests: During this visit the participant will complete several computer tasks, and the study staff will be measuring reaction time and psychophysiological measures.The tasks that the participant will perform will show three different images and an aversive stimulus (e.g. loud burst of noise or mild wrist shock) may follow one image most of the time, while the other images may never be followed by a noise or mild wrist shock. The participant will need to try to predict whether the aversive cue will occur or not based on which image is shown and will be asked to repeatedly rate on a scale how likely it is that he or she thinks a noise/shock will occur after each image. Lastly, during the session the participant will also be asked to report his or her level of anxiety on a scale from 0 to 100. Visit 3: Behavioral Tests with Drug or Placebo and MRI scan: For safety reasons participant will not be allowed to take any drugs for at least 24 hours before this visit, and should not use marijuana for at least 2 weeks before. Participants will be required to pass a urine drug test (and pregnancy test for women) and breathalyzer test before being allowed to continue with this visit. The participant will also not be allowed to drive himself or herself home from this visit, so he or she should arrange a friend or family member to pick him or her up or a taxi can be called by our research staff. The participant will view the same images he or she did on the previous day (Visit 2), and may experience the same aversive stimulus as during Visit 2. The participant will again be asked to rate how much he or she expects to experience the aversive stimulus after each image and he or she will also be asked to report his or her level of anxiety on a scale from 0 to 100. However, about 2 hours before the task begins, the participant will be asked to swallow a capsule containing either a marijuana-like drug (Dronabinol) or a placebo (sugar pill). Dronabinol is a Food & Drug Administration (FDA) approved drug and the dose (7.5mg; one time) is unlikely to have any effects that last beyond the duration of the study visit. About every 30 minutes after taking the pill, the participant will fill out some questionnaires about mood and how he or she is feeling at the moment. There will be three additional tasks that the participant will perform during this visit as well. The first task will involve looking at some unpleasant images and scenes and either maintaining his or her emotional response to the image, or using some techniques the study staff will practice with the participant to reinterpret the content of the image in a less unpleasant way. The second task will involve viewing a series of black and white line drawing of single objects and deciding whether or not each would fit into a shoe box. The third task will involve viewing a white fixation cross on a black background while the participant relaxes. Visit 4: Behavioral Tests and MRI scan: This visit will be very similar to Visit 2. Participants will participate in the same type of task inside the MRI scanner, while the study staff measures reaction time and psychophysiological responding and brain activation. Participants will view the same images he or she did previously, and may experience the same aversive stimulus as during Visit 2. Participants will again be asked to rate how much they expect to experience the aversive stimulus after each image and will also be asked to report their level of anxiety on a scale from 0 to 100. Lastly participants will also complete another decision making task involving single objects similar to that during the previous day (Visit 3).

Inclusion Criterias

Free of a lifetime Axis I or Axis II diagnosis
Free of a lifetime Axis I or Axis II diagnosis

Exclusion Criterias

Current or past Axis I psychiatric disorder [including alcohol/substance abuse of dependence disorder]
Current or past Axis I psychiatric disorder [including alcohol/substance abuse of dependence disorder]

Locations

Detroit, Michigan, 48201
Detroit, Michigan, 48201

Tracking Information

NCT #
NCT02069366
Collaborators
Not Provided
Investigators
  • Principal Investigator: Christine A. Rabinak, PhD Wayne State University
  • Christine A. Rabinak, PhD Wayne State University